Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination to treat patients with certain types of advanced endometrial carcinoma.
This combination treatment is indicated for patients whose disease has progressed after systemic therapy in any setting and are not candidates for curative surgery or radiation.
The FDA approval was based on data obtained from the Phase III KEYNOTE-775/Study 309 trial, where the combination of Keytruda and Lenvima significantly improved overall survival (OS) and progression-free survival (PFS), reducing the risk of death by 32% and the risk of disease progression or death by 40%.
Additionally, the combination treatment has led to an objective response rate (ORR) of 30% versus 15% for patients receiving either doxorubicin or paclitaxel.
Patients receiving Keytruda plus Lenvima treatment had a complete response rate of 5% compared with 3% for doxorubicin or paclitaxel, and a partial response rate of 25% versus 13%, respectively.
Merck Research Laboratories Oncology Clinical Research vice-president Dr Gregory Lubiniecki said: “When compared to the chemotherapies used in this trial, this combination treatment regimen was proven to extend the lives of certain patients diagnosed with previously treated, advanced endometrial cancer.
“Based on Phase III data, today’s approval acts as the confirmatory trial to our previous accelerated approval of Keytruda plus Lenvima in patients with certain types of advanced endometrial cancer and reinforces the impact of our joint research with Eisai in exploring the potential of this combination to treat more patients with challenging types of cancer.”
Previously, the combination treatment was approved under the FDA’s accelerated approval process, Real-Time Oncology Review pilot programme and its Project Orbis initiative to treat certain endometrial cancer patients.